Medical Device Manufacturer · US , Mchenry , IL

Biokit USA, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1984

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biokit USA, Inc. Immunology ✕

7 devices

1-7 of 7

Cleared May 31, 1991

RHEUMAGEN RF T-CONTROL

Immunology · 254d

Cleared Apr 05, 1991

Immunology · 67d

Cleared Mar 19, 1991

Immunology · 28d

Cleared Oct 01, 1990

RHEUMAGEN CRP T-CONTROL

Immunology · 12d

Cleared Nov 08, 1989

QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)

Immunology · 9d

Cleared Nov 08, 1989

QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL

Immunology · 9d

Cleared Dec 14, 1987

Immunology · 31d